Gleevec Approval Widened to Include Rare
WEDNESDAY, Feb. 1 (HealthDay News) -- U.S. Food and Drug
Administration approval for the Novartis drug Gleevec has been
expanded to include adults who have had surgical removal of
CD117-positive gastrointestinal stromal tumors (GIST), the agency
said in a news release.
GIST is a rare cancer that forms in cells that line the walls of
the GI tract, including the stomach. Such cells play a role in food
digestion and other bodily processes, the FDA said.
Gleevec, first approved in 2001 to treat a genetic disease
called Philadelphia chromosome positive chronic myeloid leukemia,
has been sanctioned subsequently for a number of forms of GIST.
Gleevec's label will be updated to include clinical study
results about CD117-positive GIST. The drug significantly increased
patient survival when taken for 36 months, compared to the standard
12 months, the FDA said.
Common clinical side effects of Gleevec included swelling,
nausea and vomiting, muscle cramps, bone or muscle pain, diarrhea,
rash, fatigue and abdominal pain.
Novartis is based in East Hanover, N.J.
The U.S. National Institutes of Health has more about
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